Registration Dossier
Registration Dossier
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EC number: 800-526-8 | CAS number: 1273322-45-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Amines, hydrogenated tallow alkyl
- EC Number:
- 262-976-6
- EC Name:
- Amines, hydrogenated tallow alkyl
- Cas Number:
- 61788-45-2
- Molecular formula:
- R-NH2 , whereas R=C16-18-(even numbered)-alkyl
- IUPAC Name:
- Amines, hydrogenated tallow alkyl
- Reference substance name:
- Hydrogenated tallow Alkylamines
- IUPAC Name:
- Hydrogenated tallow Alkylamines
- Test material form:
- other: solid wax
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: B&K UNIVERSAL G.J., S.L
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 2.3-2.5
- Housing: were individually in stainless steel cages with a grille floor
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 45-66
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eyes served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg / animal - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The observation of the cornea was completed with the installation of an aqueous solution of 2% sodium fluorescein. This procedure involved the installation of the aqueous solution of fluorescein in the test area, followed by washing the area with a 0.9% physiological saline solution.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: exposure 24 hours
- Irritation parameter:
- iris score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: exposure 24 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: exposure 24 hours
- Irritation parameter:
- chemosis score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 3.11
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: exposure 24 hours
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the findings of this study, the tested hydrogenated tallow alkylamines is considered to be severely irritating to eyes.
- Executive summary:
In an GLP compliant OECD TG 405 study, 100 mg the test material hydrogenated tallow alkyl amine, a white solid (pH = 9.93, purity 95%), was applied to the eyes of three New Zealand White rabbits. Pronounced conjunctiva redness and chemosis was observed throughout the entire observation period. Additionally, severe cornea opacity and moderate iris lesions was noted. Mean Draize scores for conjunctiva redness at 24, 48 and 72 hours were 3.0, 3.0 and 3.0. Mean scores for conjunctiva chemosis were 3.0, 3.0 and 3.3 for the same time points. These effects were not reversible within the observation period of 21 days. Related scores for iris were 1.0, 1.0 and 1.0, reversible between 14 and 21 days. Scores for cornea density were 3.0, 3.3 and 3.7, respectively and showed a value of 2.0 at the end of the observation period. Based on the findings of this study, the tested hydrogenated tallow alkylamines is considered to be severely irritating to eyes.
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